510(k) K080532
K080532 is an FDA 510(k) premarket notification submitted by Unicare Biomedical, Inc. for the device "BENACEL, MODELS C-001, C-002 AND C-005". The FDA issued a decision of Substantially Equivalent on November 12, 2008. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Unicare Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2008
- Date Received
- February 26, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
To temporarily control bleeding and cover external wounds.